Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Myeloproliferative Disorders

Bone Marrow Diseases

Hematologic Diseases

Neoplasms by Histologic Type

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Ponatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.

Ponatinib 30 mg orally once daily in each 28 day Cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS up to data cut-off: 31 May 2020. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.

Participants received ponatinib 15 mg orally once daily up to data cut-off: 31 May 2020 in each 28 day Cycle.

Study Director Clinical Science

The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as measured by \<=1 % Breakpoint Cluster Region-Abelson Transcript Level using International Scale (BCR-ABL1IS) at 12 months.

The drug being tested in this study is ponatinib. This study will characterize the safety and efficacy of ponatinib over a range of 3 starting doses.

The study will enroll 276 participants in 3 cohorts and each cohort will have 92 participants. All the participants will be randomized to receive once-daily oral administration of 1 of 3 starting doses of ponatinib:

* Cohort A: 45 mg ponatinib tablet
* Cohort B: 30 mg ponatinib tablet
* Cohort C: 15 mg ponatinib tablet

The study is designed to consist of 2 periods: 24-cycle Main treatment period and optional treatment continuation period. Participants will be treated with their randomized dose of study drug in the Main Treatment Period until the occurrence of at least one of the following: absence of CHR by 3 months, absence of MCyR at 12 months, absence of \<=1% BCR-ABL1IS at 12 months, loss of \<=1% BCR-ABL1IS development of intolerance, or completion of all 24 cycles of treatment (whichever occurs first). Following completion of approximately 5 years or following early withdrawal, participants may enter into an optional treatment continuation period.

This multi-center trial will be conducted in the United States, United Kingdom, Republic of Korea, Spain, France, Taiwan, Australia, Canada, Italy, Chile, Japan, Germany, Argentina, Poland, Czech Republic, Denmark, Hong Kong, Portugal, Russia, Singapore, Switzerland, and Sweden. The overall time to participate in this study is approximately 96 months. Participants will make a final visit to the clinic approximately 30 days after the last dose of study treatment.

Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

MR2 is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL \<=1% Breakpoint Cluster Region-Abelson Transcript Level as Measured by the International Scale (BCR-ABL1IS), equivalent to a 2-log reduction in transcript.

MMR/MR3 is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL ≤0.1% on the international scale (equivalent to a 3-log reduction in transcript).

MCyR is defined as percentage of participants with complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Cytogenetic response is the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow (BM). Response is further defined as MCyR: CCyR or PCyR, where CCyR: 0% Ph + metaphases; PCyR: \>0 to 35% Ph + metaphases.

Duration of MMR/MR3 is defined as the interval between the first assessment at which the criteria for \<=0.1% MMR are met until the earliest date at which loss of \<=0.1% MMR occurs, or the criteria for progression are met. Progression to accelerated phase (AP) is defined as: \>= 15% and \<30% blasts in peripheral blood or bone marrow or \>=20% basophils in peripheral blood or bone marrow or \>=30% blasts + promyelocytes in peripheral blood or bone marrow (but \<30% blasts) or \<100\*109 platelets per liter (/L) in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to blast Phase (BP) is defined as: \>=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly.

Percentage of participants with adjusted incidence rates who developed AOEs and VTEs were categorized according to arterial occlusive events and venous thrombotic events. AE is any untoward medical occurrence in participant administered medicinal investigational drug. Untoward medical occurrence does not necessarily have to have causal relationship with treatment. SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect/is medically important event that may not be immediately life-threatening/result in death or hospitalization, but may jeopardize participant/may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.

Cytogenetic response is defined as the percentage of Ph+ metaphases in bone marrow (peripheral blood may not be used), with a review of a minimum of 20 metaphases. CCyR is defined as 0% Ph+ metaphases.

MR4 is defined as \<=0.01% BCR-ABL1IS. MR 4.5 is defined as \<=0.0032% BCR-ALB1IS.

MR1 is defined as percentage of participants achieving a ratio of \<=10% Breakpoint Cluster Region-abelson (BCR-ABL1) transcripts on the international scale. MR1 is molecular response with 1-log reduction in transcript.

CHR is defined as achieving all of the following measurements: white blood cells (WBC) \<= institutional upper limit of normal (ULN), platelets \<450,000 per cubic millimeter (/mm\^3), no blasts or promyelocytes in peripheral blood, \<5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood \<5%, and no extramedullary involvement (including no hepatomegaly or splenomegaly).

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

DOR (≤1% BCR-ABL1IS) is defined as interval between first assessment at which criteria for ≤1% BCR-ABL1IS are met until earliest date at which loss of ≤1% BCR-ABL1IS occurs, or criteria for progression accelerated phase (AP) or blast Phase (BP) of chronic myeloid leukemia (CML) are met. Loss of ≤1% BCR-ABL1IS is an increase to \>1% of BCR-ABL1IS. Progression to AP: ≥15% and \<30% blasts in peripheral blood or bone marrow or ≥20% basophils in peripheral blood or bone marrow or ≥30% blasts + promyelocytes in peripheral blood or bone marrow (but \<30% blasts) or \<100\*109 platelets per liter in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP: ≥30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly. Kaplan-Meier method was used for analysis of percentage of participants who achieved DOR of 12 and 24 months.

Duration of MMR/MR3 is defined as interval between first assessment at which criteria for MMR are met until earliest date at which loss of MMR occurs, or criteria for progression (progression to AP or BP of CML) are met. Participants remaining in MMR will be censored at last date at which criteria for MMR are met. Loss of MMR is an increase to \>0.1% of BCR-ABL1IS. Progression to AP: \>= 15% and \<30% blasts in peripheral blood or bone marrow or \>=20% basophils in peripheral blood or bone marrow or \>=30% blasts+promyelocytes in peripheral blood or bone marrow (but \<30% blasts) or \<100\*109 platelets/L in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP: \>=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly. Kaplan-Meier method was used for analysis of percentage of participants who achieved DOR of 12 and 24 months.

Duration of response in "responders" is defined as any participants who achieved ≤1% BCR-ABL1IS at any time during the study. Responders are defined as those participants who meet all of the following: are randomized and treated, respond at 12 months after the initiation of study treatment, and undergo baseline polymerase chain reaction (PCR) assessment.

Time to response was defined as the time interval from the date of the first dose of the study drug until the initial observation of CR or PR for participants with confirmed CR/PR. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to \<10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (\<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the Baseline sum diameters.

Progression to AP is defined as: \>=15% and \<30% blasts in peripheral blood or bone marrow or \>=20% basophils in peripheral blood or bone marrow or \>=30% blasts + promyelocytes in peripheral blood or bone marrow (but \<30% blasts) or \<100\*109 platelets/L in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP is defined as: \>=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly.

PFS is defined as the interval between the first dose date of study treatment and the first date at which the criteria for progression are met (progression to the AP or BP of CML), or death due to any cause, censored at the last response assessment. Progression to AP is defined as: \>=15% and \<30% blasts in peripheral blood or bone marrow or \>=20% basophils in peripheral blood or bone marrow or \>=30% blasts + promyelocytes in peripheral blood or bone marrow (but \<30% blasts) or \<100\*109 platelets/L in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP is defined as: \>=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly.

OS is defined as the interval between the first does of study treatment and death due to any cause, censored at the last contact date when the participant was alive.

Takeda

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. All cause-mortality was collected for all randomized participants. Serious and other adverse events was collected for participants from Safety Population who received at least 1 dose of study drug.

Cohort A: Ponatinib 45 mg

Cohort B: Ponatinib 30 mg

Cohort C: Ponatinib 15 mg

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race

Race/Ethnicity, Customized

Argentina

Austria

Chile

Denmark

France

United Kingdom

Hong Kong

Italy

Japan

Poland

Russia

Singapore

Korea, Republic Of

Spain

Sweden

Taiwan, Province Of China

United States

Region of Enrollment

Weight

Number analyzed is the number of participants with data available for height at Baseline.

Height

Score= 0

Score= 1

Score= 2

ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity). Only categories with data are reported.

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score

Safety Population included all participants who received at least one dose of study drug.

Study Director

ITT Population included all participants who were randomized and for whom BCR-ABL1IS could be measured (ie, participants who had the b2a2/b3a2 transcript type), regardless of whether they received the assigned study drug.

Percentage of Participants With Molecular Response (MR2: <=1% Breakpoint Cluster Region-Abelson Transcript Level) as Measured by the International Scale (BCR-ABL1IS) at Month 12

Percentage of Participants With Major Molecular Response (MMR/MR3)

ITT Cytogenetic Population included all participants who were randomized and had a cytogenetic assessment at Baseline with ≥20 metaphases examined, regardless of whether they received the assigned study drug. Overall number analyzed are participants with data available for analysis.

Percentage of Participants With Major Cytogenetic Response (MCyR)

Duration of Major Molecular Response (MMR/MR3)

AOEs

VTEs

SAEs

Safety Population included all participants who received at least 1 dose of study drug.

Percentage of Participants With Adjusted Incidence Rates for Treatment Emergent Arterial Occlusive Events (AOEs), Venous Thrombotic Events (VTEs), Adverse Events (AEs), and Serious AEs (SAEs)

Percentage of Participants With Complete Cytogenetic Response (CCyR)

Percentage of Participants With Molecular Response 4 (MR4) and Molecular Response (MR4.5)

Percentage of Participants With Molecular Response 1 (MR1)

All randomized participants were included in the analysis.

Percentage of Participants With Complete Hematologic Response (CHR)

TEAEs Leading to Treatment Discontinuation

TEAEs Leading to Dose Reduction

TEAEs Leading to Dose Interruption

Percentage of Participants With Treatment Emergent AEs Leading to Treatment Discontinuation, Dose Reduction and Dose Interruption

Month 12

Month 24

ITT Population included all participants who were randomized and for whom BCR-ABL1IS could be measured (ie, participants who had the b2a2/b3a2 transcript type), regardless of whether they received the assigned study drug. Data is reported for responders.

Kaplan-Meier Estimate of Duration of Response (DOR) of <=1% BCR-ABL1 IS (MR2) at Months 12 and 24

Kaplan-Meier Estimate of Duration of Response (DOR) of Major Molecular Response (MMR/MR3)

Duration of Response in Responders

ITT Population included all participants who were randomized and for whom BCR-ABL1IS could be measured (ie, participants who had the b2a2/b3a2 transcript type), regardless of whether they received the assigned study drug. Data is reported for the responders.

Time to Response

Progressed to AP-CML

Progressed to BP-CML

Percentage of Participants With Progression to Accelerated Phase (AP)-Chronic Myeloid Leukemia (CML) or Blast Phase (BP)-CML

Progression-free Survival (PFS)

Overall Survival (OS)

Overall Study

At each follow up visit, plasma concentrations of ponatinib will be measured and compared with therapeutic range (according to a lower concentration equal to 21 nM)

Therapeutic drug monitoring

BCR-ABl transcript levels will be assessed to evaluate molecular response to ponatinib

Molecular Response

Sara Galimberti, PhD

Claudia Baratè, MD

Giovanni Caocci, PhD

Alessandra Iurlo, MD

Luigia Luciano, MD

Federica Ricci, MD

Marinunzia Franciosa, MD

Ignazio Santo, MD

Antonello Di Paolo, MD

Francesca Guerrini, BiolD

Elisabetta Abruzzese, MD

The goal of this retrospective observational study is to evaluate any possible association between plasma concentrations of ponatinib and its pharmacodynamics (efficacy/tolerability) in patients affected by chronic myeloid leukemia in chronic phase (CML-CP).

In particular, the aims of the study will be:

* primary aim: to investigate the relationships (if any) between plasma concentrations and activity/toxicity of ponatinib in a population of CML-CP patients enrolled in several Italian hematological centers;
* secondary aim: to set up an algorithm aimed at helping physicians to improve drug dosing based on several variables (i.e., plasma drug concentrations, tolerability, molecular response to therapy).

The study will enroll CML-CP patients who were exposed to ponatinib as second, third or fourth line of chemotherapy.

The study protocol is a non-interventional, retrospective observational study which involves the collection of data from medical records relating to the plasma dosages of ponatinib performed as per clinical practice, all carried out at the pharmacokinetics laboratory of the U.O. Clinical Pharmacology and Pharmacogenetics of AOUP. These data will be collected in CRF and will be correlated to efficacy data (extent of molecular response) and toxicity of ponatinib (haematological, extra-haematological adverse events, together with adverse event severity). Real-life experience (dosage adjustments made by clinicians based on plasma dosage) will be used to propose an algorithm that can help in choosing the correct dosage of ponatinib.

Classical statistical analyses (for descriptive and comparison aims) will be used according to their appropriateness. Moreover, factors affecting the pharmacokinetics of ponatinib will be investigated by nonlinear mixed effect modeling adopting the MONOLIX 2021R2 suite. Final model will be used as parte of the dosing algorithm.

Notably, all clinical and laboratory data will be anonymized to protect patients' privacy, and harvested in a database that will be used to perform pharmacometric and statistical analyses.

Ponatinib in CML Patients in Chronic Phase

Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol

Plasma concentrations of ponatinib included in the therapeutic range (i.e., \>21 nM)

Adverse events/Adverse drug reactions observed and registered during ponatinib administration

University of Pisa

Professor of Pharmacology

Philadelphia Chromosome

Translocation, Genetic

Chromosome Aberrations

Nilotinib

Imatinib Mesylate

Nilotinib 300 mg is taken by mouth twice a day at 12 hour intervals. Nilotinib is to be taken with water on an empty stomach. No food two hours prior to the dose of nilotinib and for one hour following the dose.

Novartis Pharmaceuticals

This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib

Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

A Multi-center, Open-label, Exploratory Study of Bcr-Abl Kinetics in Adult Patients on Nilotinib With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) and a Suboptimal Molecular Response to Imatinib

The change on a logarithmic scale at 12 months from a standardized baseline value (100% on the international scale \[IS\]) in Bcr-Abl transcripts as assessed by peripheral blood Quantitative real-time polymerase chain reaction (RQ-PCR).

Major Molecular Response (MMR) value at molecular MD is designated a percentage, which is equivalent to a 3-log reduction from a standardized baseline value from the International Randomized InteYesrferon versus STI571 (IRIS) study or 0.1 percent (%) per International Scale (IS).

Number of participants experiencing either a greater than or equal to (\>or=) 1, \>or= 2, or \>or= 3 log10 reduction in Bcr-Abl transcript levels from Baseline to End of Cycle (EOC) 45 (Day1219 - Day1302) were presented.

The median time to best molecular response, defined as the time (in months) from the date of enrollment to the date when the maximum reduction in Bcr-Abl transcript level was observed.

Duration of best molecular response, defined as the time (in months) from the date of best molecular response to a date when an increase in \>1 log10 was observed

Event-free survival was defined as the number of participants from the date of enrollment to the date of first occurrence of any of the following: loss of complete hematological response (CHR), loss of Complete cytogenetic response (CCyR), \>1 log increase in Bcr-Abl transcripts from the lowest recorded value, progression to accelerated or blast phase, and death.

Progression-free survival was defined as the number of participants from the date of enrollment to the date of first occurrence of progression to Accelerated phase (AP) or Blast crisis (BC) phase, chronic myelogenous leukemia (CML) or death. Participants who did not have an event or dropped out without an event are considered censored at the date of the last observed event.

Overall survival was defined as the number of participants from enrollment to the date of death.

The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.

Participants orally received a total of 600 mg dose of Nilotinib as a as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).

Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).

Caucasian

Black

Asian

Other

The analysis was performed in Intent-to-treat (ITT) population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment.

The study was terminated on 31 March 2012 due to slower than planned enrollment, resulting in a small sample size, no inferential analyses were conducted.

Baseline

The analysis was performed in intent-to-treat (ITT) population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed refer to the number of participants evaluable for this outcome measure at specified time point.

Log Change From Baseline in Breakpoint Cluster Region Gene (BCR) - Abelson Proto-oncogene (ABL) (Bcr-Abl) Transcript Levels

The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment.

Number of Participants Who Achieved Major Molecular Response (MMR)

>or=1 log10 reduction

>or= 2 log10 reduction

>or= 3 log10

The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

Number of Participants Achieved Reduction From a Standardized Baseline Value in Bcr-Abl Transcript Levels up to Month 12

Median Time to Best Molecular Response

Since only one participant met the criterion of losing response (that is \[i.e.,\] an increase in \> 1 log10 is observed after the occurrence of best molecular response), the analysis was not performed. Hence data was not collected and reported.

Duration of Best Molecular Response

Event

Censor

The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment. Participants who did not have an event or dropped out without an event are considered censored at the date of the last observed event.

Number of Participants With an Event-free Survival

Missing

Number of Participants With a Progression-free Survival

Number of Participants With an Overall Survival

Participants orally received a total of 600 milligram (mg) dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules twice daily (BID) for 12 cycles (each cycle = 28 days).

Participants with newly diagnosed CML in chronic phase received nilotinib 300 mg BID for 24 months

A daily dose of 300 mg was given to all participants as two 150 mg capsules BID. The prescription of study drug was not study dependent and followed medical needs of the participant only. The study treatment was administered for 24 months.

The main purpose of this study was to evaluate the rate of deep molecular response (MR4.5) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase chronic myeloid leukemia (CML) using EUTOS (European Treatment and Outcome Study for CML)-standardized laboratories. All participants received nilotinib 300 mg twice daily (BID).

This was a Phase IV open-label, multi-center, single-arm study in participants with newly diagnosed Philadelphia chromosome positive (Ph+) CML in chronic phase for who nilotinib is the appropriate treatment at the discretion of the investigator.

A screening period of 2 weeks was used to assess eligibility and to taper participants off disallowed medications. Participants whose eligibility was confirmed entered a 24 months treatment phase with nilotinib 300mg BID. Nilotinib was prescribed by the investigator according to the individual needs of the participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses	NCT02467270	Myeloid Leukemi...	Ponatinib	18 Years -	Takeda
Ponatinib in CML Patients in Chronic Phase	NCT06119269	Chronic Myeloid...	Therapeutic dru... Molecular Respo...	18 Years -	University of Pisa
Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib	NCT00644878	Chronic Myeloge...	Nilotinib	18 Years -	Novartis
Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.	NCT02546674	Chronic Myeloid...	Nilotinib	18 Years - 120 Years	Novartis
Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation	NCT04666259	Chronic Myeloge...	ABL001	18 Years -	Novartis
Ponatinib in CML Patients in Chronic Phase	NCT06119269	Chronic Myeloid...	Therapeutic dru... Molecular Respo...	18 Years -	University of Pisa
Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Relapsed or Refractory Follicular Lymphoma	NCT00366275	Follicular Lymp...	Immunochemother...	18 Years - 60 Years	IRCCS Policlinico S. Matteo
Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Relapsed or Refractory Follicular Lymphoma	NCT00366275	Follicular Lymp...	Immunochemother...	18 Years - 60 Years	IRCCS Policlinico S. Matteo

Spots Global Cancer Trial Database for molecular response